不可逆电穿孔联合化疗治疗局部晚期癌症患者的安全性和生存率评价:一项回顾性观察研究

Chaobin He, Jun Wang, Y. Mao, X. Lao, Sheng-ping Li
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The study was approved by the Institutional Review Board of Sun Yat-sen University Cancer Center (approval No. C2021-003). Results: The median survival of all included patients were 24.63 (95% confidence interval: 21.78–27.49) for overall survival and 13.00 (95% confidence interval: 8.81–17.19) months for progression-free survival, with 96.8%, 51.9%, 18.3%; and 52.3%, 21.5%, 7.9% as the 1-, 2- and 3-year OS and PFS rates, respectively. Tumor size [OS, hazard ratio (HR)=1.768, P = 0.048; PFS, HR = 0.304, P = 0.010], neoadjuvant chemotherapy (OS, HR = 0.338, P = 0.030; PFS, HR = 0.358, P = 0.034), carbohydrate antigen 19-9 variation after IRE (OS, HR = 19.320, P = 0.003; PFS, HR = 14.591, P = 0.021) and tumor response after neoadjuvant chemotherapy (OS, HR = 8.779, P = 0.033; PFS, HR = 5.562, P = 0.008) were predictive factors of survival in patients with LAPC after IRE. Complications were observed in 20.3% of patients. Grade B pancreatic fistula was the most common complication. 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引用次数: 0

摘要

摘要目的:不可逆电穿孔(IRE)是一种治疗局部晚期癌症(LAPC)的新方法。我们旨在对接受IRE联合化疗的LAPC患者进行生存和安全性分析。方法:回顾性收集2015年8月至2019年3月在中山大学癌症中心接受IRE和化疗的64例LAPC患者。使用Kaplan-Meier方法评估总生存率(OS)和无进展生存率(PFS),并通过对数秩检验进行比较。多变量Cox回归模型用于确定生存的预后因素。同时对IRE的围手术期并发症进行了评估。本研究经中山大学癌症中心机构审查委员会批准(批准号C2021-003)。结果:所有纳入患者的中位生存率为24.63(95%置信区间:21.78-27.49),无进展生存期为13.00(95%可信区间:8.81-17.19)个月,分别为96.8%、51.9%和18.3%;1年、2年和3年OS和PFS的发生率分别为52.3%、21.5%和7.9%。肿瘤大小[OS,危险比(HR)=1.768,P = 0.048;PFS,小时 = 0.304,P = 0.010],新辅助化疗(OS,HR = 0.338,P = 0.030;PFS,小时 = 0.358,P = 0.034),IRE后碳水化合物抗原19-9变异(OS,HR = 19.320,P = 0.003;PFS,小时 = 14.591,P = 0.021)和新辅助化疗后的肿瘤反应(OS,HR = 8.779,P = 0.033;PFS,小时 = 5.562,P = 0.008)是IRE后LAPC患者生存的预测因素。20.3%的患者出现并发症。B级胰瘘是最常见的并发症。晚期治疗组的并发症发生率(6.1%)明显低于IRE治疗后的前15名患者(66.7%) 天,也比早期治疗组短(10.0 天)。结论:IRE联合化疗可提高LAPC患者的生存率,并发症发生率可接受。因此,它可能是一种适用于LAPC的方法,但应在前瞻性随机试验中进行验证。
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An evaluation of safety and survival for patients with locally advanced pancreatic cancer treated with irreversible electroporation combined with chemotherapy: a retrospectively observational study
Abstract Objective: Irreversible electroporation (IRE) is emerging as a new therapy for locally advanced pancreatic cancer (LAPC). We aimed to conduct survival and safety analyses in LAPC patients after treatment with IRE combined with chemotherapy. Methods: A total of 64 patients with LAPC who had received IRE and chemotherapy were retrospectively collected from August 2015 to March 2019 at Sun Yat-sen University Cancer Center. Overall survival (OS) and progression-free survival (PFS) were evaluated using Kaplan-Meier method and compared by the log-rank test. A multivariate Cox regression model was used to determine the prognostic factors of survival. The perioperative complications of IRE were also evaluated. The study was approved by the Institutional Review Board of Sun Yat-sen University Cancer Center (approval No. C2021-003). Results: The median survival of all included patients were 24.63 (95% confidence interval: 21.78–27.49) for overall survival and 13.00 (95% confidence interval: 8.81–17.19) months for progression-free survival, with 96.8%, 51.9%, 18.3%; and 52.3%, 21.5%, 7.9% as the 1-, 2- and 3-year OS and PFS rates, respectively. Tumor size [OS, hazard ratio (HR)=1.768, P = 0.048; PFS, HR = 0.304, P = 0.010], neoadjuvant chemotherapy (OS, HR = 0.338, P = 0.030; PFS, HR = 0.358, P = 0.034), carbohydrate antigen 19-9 variation after IRE (OS, HR = 19.320, P = 0.003; PFS, HR = 14.591, P = 0.021) and tumor response after neoadjuvant chemotherapy (OS, HR = 8.779, P = 0.033; PFS, HR = 5.562, P = 0.008) were predictive factors of survival in patients with LAPC after IRE. Complications were observed in 20.3% of patients. Grade B pancreatic fistula was the most common complication. The complication rates of the late treatment group (6.1%) were significantly lower than those of the first 15 patients after IRE treatment (66.7%). The median length of hospital stay of late treatment group was 8.6 days, which was also shorter than that of the early treatment group (10.0 days). Conclusions: IRE combined with chemotherapy could improve survival of LAPC patients with acceptable complication rates. Therefore, it may be a suitable method for LAPC but should be validated in prospective randomized trials.
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